GlioblastomaPhase 1NCT01430351
Temozolomide, Memantine Hydrochloride, Mefloquine, and Metformin Hydrochloride in Treating Patients With Glioblastoma Multiforme After Radiation Therapy
A Phase 1 study testing Mefloquine, Memantine Hydrochloride and Metformin Hydrochloride in people with Glioblastoma and Gliosarcoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This phase I trial studies the side effects and best dose of combination chemotherapy in treating patients with glioblastoma multiforme after radiation therapy. Drugs used in chemotherapy, such as temozolomide, memantine hydrochloride, and metformin hydrochloride, work in different ways to stop the growth of tumor… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma, Gliosarcoma, Supratentorial Glioblastoma
- What is being tested?
- Mefloquine, Memantine Hydrochloride and Metformin Hydrochloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2011to 2 Feb 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with histologically proven supratentorial glioblastoma or gliosarcoma (World Health Organization [WHO] grade IV astrocytoma) will be eligible for this protocol; patients will be eligible if the original histology was low-grade glioma and a subsequent histological diagnosis of glioblastoma or gliosarcoma is made prior to any definitive treatment (radiotherapy, chemotherapy)
- All patients must sign an informed consent indicating that they are aware of the investigational nature of this study; patients must be registered prior to treatment with study drug
- Patients must have a Karnofsky performance status (KPS) of >= 60
- White blood cells (WBC) >= 3,000/ul (performed within 14 days prior to registration)
- Absolute neutrophil count (ANC) >= 1,500/mm^3 (performed within 14 days prior to registration)
- Platelet count of >= 100,000/mm^3 (performed within 14 days prior to registration)
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- Hemoglobin >= 10 gm/dl (eligibility level for hemoglobin may be reached by transfusion) (performed within 14 days prior to registration)
- Serum glutamic oxaloacetic transaminase (SGOT) < 2 times upper limit of normal (ULN) (performed within 14 days prior to registration)
- Bilirubin < 2 times ULN (performed within 14 days prior to registration)
- Creatinine < 1.5 mg/dL (performed within 14 days prior to registration)
- For patients on mefloquine arm, a baseline electrocardiogram (EKG) without evidence of prolonged corrected QT (QTc) interval > 450 ms or clinically significant arrhythmia must be obtained within 14 days prior to registration
- A brain scan should be performed within 14 days prior to registration and steroid dosing should be stable or decreasing for at least 5 days; if the steroid dose is increased between the date of imaging and registration a new baseline magnetic resonance (MR)/computed tomography (CT) is required; the same type of scan, i.e., magnetic resonance imaging (MRI) or CT must be used throughout the period of protocol treatment for tumor measurement
- Patients must have completed standard radiation therapy with concurrent TMZ and must not have evidence of progressive disease on post treatment imaging
- Women of childbearing potential must have a negative serum or urine beta-human chorionic gonadotropin (B-HCG) pregnancy test documented within 72 hours of start of therapy
- Patients must be registered on the study within 5 weeks of completion of concurrent chemoradiation
Who cannot join
- Patients must not have any significant medical illnesses that, in the investigator's opinion, cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy
- For mefloquine arm, patients with evidence of QTc interval > 450 ms or clinically significant arrhythmia on baseline EKG obtained within 14 days of registration will be ineligible for protocol enrollment
- Patients with a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission and off of all therapy for that disease for a minimum of 3 years, are ineligible
- Patients must not have active infection or serious intercurrent medical illness
- Patients must not be pregnant/breast feeding and must agree to practice adequate contraception (acceptable forms of birth control include condom with spermicide and/or diaphragm with spermicide, and non-barrier contraception such as tubal ligation, vasectomy, oral contraceptives, implanted levonorgestrel, vaginal hormonal contraceptive ring)
- Patients must not have any disease that will obscure toxicity or dangerously alter drug metabolism; patients with a history of psychosis/schizophrenia or cardiac disease requiring beta-blocker treatment (unable to change medication to non-beta blocker), anti-malarial drugs, or quinine or quinidine will not be eligible for enrollment to a mefloquine containing arm; patients who are on active treatment with one of the study drugs at the time of evaluation will not be eligible for enrollment to an arm containing that study drug
- For mefloquine arm, patients must not be on enzyme inducing anticonvulsants (EIAED); if the treating physician elects to change the medication to a non-enzyme inducing agent, a 2-week wash out period will be required after stopping EIAED prior to initiation of treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Lead-In to a 2x2x2 Factorial Trial of Temozolomide, Memantine, Mefloquine, and Metformin as Post-Radiation Adjuvant Therapy of Glioblastoma Multiforme
This phase I trial studies the side effects and best dose of combination chemotherapy in treating patients with glioblastoma multiforme after radiation therapy. Drugs used in chemotherapy, such as temozolomide, memantine hydrochloride, and metformin hydrochloride, work in different ways to stop the growth of tumor cells, either by killing them or stopping them from dividing. Mefloquine may help temozolomide, memantine hydrochloride, and metformin hydrochloride kill more cancer cells by making tumor cells more sensitive to the drug. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the safety and tolerability of temozolomide (TMZ) in combination with metformin (metformin hydrochloride) (MFRMN) and/or mefloquine (MFLOQ) and/or memantine (memantine hydrochloride) (MEMTN) in patients receiving adjuvant therapy after completing external beam radiotherapy (XRT) in combination with chemotherapy for newly diagnosed glioblastoma multiforme (GBM).
SECONDARY OBJECTIVES:
- To determine the median progression free survival (PFS); 6, 12, and 18 month PFS; and median overall survival (OS) in patients treated with temozolomide and a combination of metformin and/or mefloquine and/or memantine.
OUTLINE: This is a dose-escalation study. Patients are randomized to 1 of 8 different treatment arms.
ARM 1: Patients receive temozolomide orally (PO) once daily (QD) on days 1-5.
ARM 2: Patients receive temozolomide PO as in Arm 1 and memantine hydrochloride PO twice daily (BID).
ARM 3: Patients receive temozolomide PO as in Arm 1 and 30 mg mefloquine PO QD on days 1-3 of week 1 and then days 2, 4, and 6 every other week.
ARM 4: Patients receive temozolomide PO as in Arm 1 and metformin hydrochloride PO BID.
ARM 5: Patients receive temozolomide PO and memantine hydrochloride PO BID as in Arm 2, and mefloquine PO QD as in Arm 3.
ARM 6: Patients receive temozolomide PO and memantine hydrochloride PO BID as in Arm 2, and metformin hydrochloride PO BID as in Arm 4.
ARM 7: Patients receive temozolomide PO as in Arm 1, mefloquine PO QD as in Arm 3, and metformin hydrochloride PO BID as in Arm 4.
ARM 8: Patients receive temozolomide PO and memantine hydrochloride PO BID as in Arm 2, metformin hydrochloride PO BID as in Arm 4, and mefloquine PO QD as in Arm 3.
In all arms, courses repeat every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months.
- Conditions
- Glioblastoma, Gliosarcoma, Supratentorial Glioblastoma
- Being tested
- Mefloquine, Memantine Hydrochloride, Metformin Hydrochloride, Temozolomide
- Medical subject headings
- Glioblastoma, Gliosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MefloquineDrug
Given PO
Memantine HydrochlorideDrug
Also called Ebixia, Namenda
Given PO
Metformin HydrochlorideDrug
Also called APO-Metformin, Cidophage, Dimefor, Glifage
Given PO
TemozolomideDrug
Also called CCRG-81045, Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-, M & B 39831, M and B 39831
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 (temozolomide) | Experimental | Patients receive temozolomide PO QD on days 1-5. Receives: Drug: Temozolomide |
| Arm 2 (temozolomide, memantine hydrochloride) | Experimental | Patients receive temozolomide PO as in Arm 1 and memantine hydrochloride PO BID. Receives: Drug: Memantine Hydrochloride; Drug: Temozolomide |
| Arm 3 (temozolomide, mefloquine) | Experimental | Patients receive temozolomide PO as in Arm 1 and 30 mg mefloquine PO QD on days 1-3 of week 1 and then days 2, 4, and 6 every other week. Receives: Drug: Mefloquine; Drug: Temozolomide |
| Arm 4 (temozolomide, metformin hydrochloride) | Experimental | Patients receive temozolomide PO as in Arm 1 and metformin hydrochloride PO BID. Receives: Drug: Metformin Hydrochloride; Drug: Temozolomide |
| Arm 5 (temozolomide, memantine hydrochloride, mefloquine) | Experimental | Patients receive temozolomide PO and memantine hydrochloride PO BID as in Arm 2, and mefloquine PO QD as in Arm 3. Receives: Drug: Mefloquine; Drug: Memantine Hydrochloride; Drug: Temozolomide |
| Arm 6 (temozolomide, memantine hydrochloride, metformin) | Experimental | Patients receive temozolomide PO and memantine hydrochloride PO BID as in Arm 2, and metformin hydrochloride PO BID as in Arm 4. Receives: Drug: Memantine Hydrochloride; Drug: Metformin Hydrochloride; Drug: Temozolomide |
| Arm 7 (temozolomide, mefloquine, metformin hydrochloride) | Experimental | Patients receive temozolomide PO as in Arm 1, mefloquine PO QD as in Arm 3, and metformin hydrochloride PO BID as in Arm 4. Receives: Drug: Mefloquine; Drug: Metformin Hydrochloride; Drug: Temozolomide |
| Arm 8 (TMZ, memantine hydrochloride, metformin, mefloquine) | Experimental | Patients receive temozolomide PO and memantine hydrochloride PO BID as in Arm 2, metformin hydrochloride PO BID as in Arm 4, and mefloquine PO QD as in Arm 3. Receives: Drug: Mefloquine; Drug: Memantine Hydrochloride; Drug: Metformin Hydrochloride; Drug: Temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of toxicities graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Measured: During first 28 days
Secondary outcomes (3)
Median progression free survival (PFS)
Measured: Up to 4 years
PFS
Measured: Up to 18 months
Median overall survival (OS)
Measured: Up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2011 (estimated)
- Study start14 Sep 2011
- Primary completion2 Feb 2025
- Study completion2 Feb 2025
Why it stopped: \<75 % participant accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Vinay Puduvalli, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01430351
- Sponsor's protocol ID
- 2011-0374
- Other IDs
- NCI-2011-03038, 2011-0374
- Status last verified
- May 2025
- First submitted
- 6 Sep 2011
- Last updated
- 7 May 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Lead-In to a 2x2x2 Factorial Trial of Temozolomide, Memantine, Mefloquine, and Metformin as Post-Radiation Adjuvant Therapy of Glioblastoma Multiforme
- ClinicalTrials.gov ID
- NCT01430351
- Acronym / sponsor ID
- 2011-0374
- Conditions
- Glioblastoma, Gliosarcoma, Supratentorial Glioblastoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: \<75 % participant accrual
- Enrolment
- 144 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 14 Sep 2011 (actual)
- Primary completion
- 2 Feb 2025 (actual)
- Study completion
- 2 Feb 2025 (actual)
- First posted
- 8 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase I trial studies the side effects and best dose of combination chemotherapy in treating patients with glioblastoma multiforme after radiation therapy. Drugs used in chemotherapy, such as temozolomide, memantine hydrochloride, and metformin hydrochloride, work in different ways to stop the growth of tumor cells, either by killing them or stopping them from dividing. Mefloquine may help temozolomide, memantine hydrochloride, and metformin hydrochloride kill more cancer cells by making tumor cells more sensitive to the drug. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
Detailed description
PRIMARY OBJECTIVES:
- To determine the safety and tolerability of temozolomide (TMZ) in combination with metformin (metformin hydrochloride) (MFRMN) and/or mefloquine (MFLOQ) and/or memantine (memantine hydrochloride) (MEMTN) in patients receiving adjuvant therapy after completing external beam radiotherapy (XRT) in combination with chemotherapy for newly diagnosed glioblastoma multiforme (GBM).
SECONDARY OBJECTIVES:
- To determine the median progression free survival (PFS); 6, 12, and 18 month PFS; and median overall survival (OS) in patients treated with temozolomide and a combination of metformin and/or mefloquine and/or memantine.
OUTLINE: This is a dose-escalation study. Patients are randomized to 1 of 8 different treatment arms.
ARM 1: Patients receive temozolomide orally (PO) once daily (QD) on days 1-5.
ARM 2: Patients receive temozolomide PO as in Arm 1 and memantine hydrochloride PO twice daily (BID).
ARM 3: Patients receive temozolomide PO as in Arm 1 and 30 mg mefloquine PO QD on days 1-3 of week 1 and then days 2, 4, and 6 every other week.
ARM 4: Patients receive temozolomide PO as in Arm 1 and metformin hydrochloride PO BID.
ARM 5: Patients receive temozolomide PO and memantine hydrochloride PO BID as in Arm 2, and mefloquine PO QD as in Arm 3.
ARM 6: Patients receive temozolomide PO and memantine hydrochloride PO BID as in Arm 2, and metformin hydrochloride PO BID as in Arm 4.
ARM 7: Patients receive temozolomide PO as in Arm 1, mefloquine PO QD as in Arm 3, and metformin hydrochloride PO BID as in Arm 4.
ARM 8: Patients receive temozolomide PO and memantine hydrochloride PO BID as in Arm 2, metformin hydrochloride PO BID as in Arm 4, and mefloquine PO QD as in Arm 3.
In all arms, courses repeat every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Arm 1 (temozolomide) | Experimental | Drug: TemozolomidePatients receive temozolomide PO QD on days 1-5. |
| Arm 2 (temozolomide, memantine hydrochloride) | Experimental | Drug: Memantine Hydrochloride, Drug: TemozolomidePatients receive temozolomide PO as in Arm 1 and memantine hydrochloride PO BID. |
| Arm 3 (temozolomide, mefloquine) | Experimental | Drug: Mefloquine, Drug: TemozolomidePatients receive temozolomide PO as in Arm 1 and 30 mg mefloquine PO QD on days 1-3 of week 1 and then days 2, 4, and 6 every other week. |
| Arm 4 (temozolomide, metformin hydrochloride) | Experimental | Drug: Metformin Hydrochloride, Drug: TemozolomidePatients receive temozolomide PO as in Arm 1 and metformin hydrochloride PO BID. |
| Arm 5 (temozolomide, memantine hydrochloride, mefloquine) | Experimental | Drug: Mefloquine, Drug: Memantine Hydrochloride, Drug: TemozolomidePatients receive temozolomide PO and memantine hydrochloride PO BID as in Arm 2, and mefloquine PO QD as in Arm 3. |
| Arm 6 (temozolomide, memantine hydrochloride, metformin) | Experimental | Drug: Memantine Hydrochloride, Drug: Metformin Hydrochloride, Drug: TemozolomidePatients receive temozolomide PO and memantine hydrochloride PO BID as in Arm 2, and metformin hydrochloride PO BID as in Arm 4. |
| Arm 7 (temozolomide, mefloquine, metformin hydrochloride) | Experimental | Drug: Mefloquine, Drug: Metformin Hydrochloride, Drug: TemozolomidePatients receive temozolomide PO as in Arm 1, mefloquine PO QD as in Arm 3, and metformin hydrochloride PO BID as in Arm 4. |
| Arm 8 (TMZ, memantine hydrochloride, metformin, mefloquine) | Experimental | Drug: Mefloquine, Drug: Memantine Hydrochloride, Drug: Metformin Hydrochloride, Drug: TemozolomidePatients receive temozolomide PO and memantine hydrochloride PO BID as in Arm 2, metformin hydrochloride PO BID as in Arm 4, and mefloquine PO QD as in Arm 3. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patients with histologically proven supratentorial glioblastoma or gliosarcoma (World Health Organization [WHO] grade IV astrocytoma) will be eligible for this protocol; patients will be eligible if the original histology was low-grade glioma and a subsequent histological diagnosis of glioblastoma or gliosarcoma is made prior to any definitive treatment (radiotherapy, chemotherapy)
- All patients must sign an informed consent indicating that they are aware of the investigational nature of this study; patients must be registered prior to treatment with study drug
- Patients must have a Karnofsky performance status (KPS) of >= 60
- White blood cells (WBC) >= 3,000/ul (performed within 14 days prior to registration)
- Absolute neutrophil count (ANC) >= 1,500/mm^3 (performed within 14 days prior to registration)
Key exclusion criteria (7 listed)
- Patients must not have any significant medical illnesses that, in the investigator's opinion, cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy
- For mefloquine arm, patients with evidence of QTc interval > 450 ms or clinically significant arrhythmia on baseline EKG obtained within 14 days of registration will be ineligible for protocol enrollment
- Patients with a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission and off of all therapy for that disease for a minimum of 3 years, are ineligible
- Patients must not have active infection or serious intercurrent medical illness
- Patients must not be pregnant/breast feeding and must agree to practice adequate contraception (acceptable forms of birth control include condom with spermicide and/or diaphragm with spermicide, and non-barrier contraception such as tubal ligation, vasectomy, oral contraceptives, implanted levonorgestrel, vaginal hormonal contraceptive ring)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MefloquineGiven PO | Drug | Arm 3 (temozolomide, mefloquine), Arm 5 (temozolomide, memantine hydrochloride, mefloquine), Arm 7 (temozolomide, mefloquine, metformin hydrochloride), Arm 8 (TMZ, memantine hydrochloride, metformin, mefloquine) |
| Memantine HydrochlorideAlso: Ebixia, NamendaGiven PO | Drug | Arm 2 (temozolomide, memantine hydrochloride), Arm 5 (temozolomide, memantine hydrochloride, mefloquine), Arm 6 (temozolomide, memantine hydrochloride, metformin), Arm 8 (TMZ, memantine hydrochloride, metformin, mefloquine) |
| Metformin HydrochlorideAlso: APO-Metformin, Cidophage, Dimefor, GlifageGiven PO | Drug | Arm 4 (temozolomide, metformin hydrochloride), Arm 6 (temozolomide, memantine hydrochloride, metformin), Arm 7 (temozolomide, mefloquine, metformin hydrochloride), Arm 8 (TMZ, memantine hydrochloride, metformin, mefloquine) |
| TemozolomideAlso: CCRG-81045, Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-, M & B 39831, M and B 39831Given PO | Drug | Arm 1 (temozolomide), Arm 2 (temozolomide, memantine hydrochloride), Arm 3 (temozolomide, mefloquine), Arm 4 (temozolomide, metformin hydrochloride), Arm 5 (temozolomide, memantine hydrochloride, mefloquine), Arm 6 (temozolomide, memantine hydrochloride, metformin), Arm 7 (temozolomide, mefloquine, metformin hydrochloride), Arm 8 (TMZ, memantine hydrochloride, metformin, mefloquine) |
Primary outcome
Incidence of toxicities graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Time frame: During first 28 days
3 secondary outcomes
Median progression free survival (PFS)
Time frame: Up to 4 years
PFS
Time frame: Up to 18 months
Median overall survival (OS)
Time frame: Up to 4 years
Results and safety
The study was stopped early (reason given: \<75 % participant accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vinay Puduvalli principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Mefloquine, Memantine Hydrochloride and Metformin Hydrochloride in people with Glioblastoma and Gliosarcoma, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: \<75 % participant accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of toxicities graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (time frame: During first 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2025.